Spinal cord stimulator implanted on (b)(6) 2017, device model name nipg1500, serial number (b)(4).On (b)(6) 2018 stimulator was not working properly, dr.(b)(6) determined a defective bracket that held the lead caused the spinal cord stimulator to malfunction, causing the stimulator to stop working.Surgery on (b)(6) 2018 for the removal of lead, battery, and bracket and replacement of lead, model, lead1058-50b, serial number (b)(4) (see attached pictures of compressed lead that was removed and the defective bracket).Then, in 2020 discovered one lead of the spinal cords stimulator was not working again, required additional surgery and replacement.Decided to seek other consultation, dr.(b)(6), (b)(6) institute performed surgery on (b)(6) 2020 to remove the spinal cord stimulator and lumbar spinal fusion.Another surgery was required on (b)(6) 2020 after the spinal fusion for the removal of disk herniation.Fda safety report id # (b)(4).
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